Job Description

  • Supports the R&D Quality (RDQ) Compliance Managers in the following areas:
    • Input of audit responses into QMS
    • Input of site inspection data into the Inspection Management System
    • Working with deviation owners to ensure the timely development and closure of CAPAs. Ensuring deviation owners are submitting objective evidence within agreed timelines, where applicable
    • Ensuring the timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee
    • Collaboration with the Clinical Study Team, as directed by the RDQ Compliance Manager, to facilitate communication
  • Prepare weekly metric reports for the General Medicine team, including, but not limited to, open deviations, CAPAs, serious breaches, audit and inspection findings. Highlighting overdue items and supporting the RDQ compliance managers to ensure timely closure.
  • Working with the RDQ Compliance Manager and data quality analytics t...

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